Manager, Regulatory Operations - UKLocation London, United Kingdom Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
OVERVIEW: BioMarin Regulatory Affairs
BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
BioMarin Regulatory Affairs Operations function has a lead role in overall BioMarin Regulatory Submission planning, execution and submission system end user technical support. Specifically, this team develops and maintains submission processes, templates, standards, and guide sheets and will format, publish, transmit, track and archive all Regulatory submission types. This group will also provide training and complex system user issues involved in the preparation of materials for submission.
The Regulatory Operations Manager may have the role of Operations Lead for an assigned product / program and oversee submission planning, including scheduling, resource allocation, formatting, QC, publishing, transmitting, and archiving regulatory submissions in both paper and electronic media to health authorities in the US, EU, CA and Rest of World. In addition to the oversight of systems and technical support as needed.
Submission Planning Leadership and Communication
· Oversee the development and maintenance of processes, templates, standards, and guide sheets
· Independently format, publish, transmit and archive all submission types; maintain templates
· Track status of submissions and project assignments; provide status updates and other communications to Regulatory Operations Management
· Manage timelines for submission calendar
· Participate in GRT and related sub-team meetings as needed and ensure adequate follow-up
· Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs
· Trouble shoot complex system user issues (such as interpreting technical validation errors)
People Development (for management track)
· Manage internal Regulatory Operations personnel as well as the activities of external consultants.
· Foster a culture that promotes respect, teamwork, collaboration, openness, and appreciation
· Mentor junior Regulatory Operations team members to build collaborative and effective working relationships and promote professional growth and the development of high-quality deliverables
· Stay abreast of new guidance released by health agencies and coach team members on interpretation as needed
· Perform regulatory intelligence for information pertinent to Regulatory Operations and provide a preliminary assessment of impact of new or modified regulations and guidance
· Support due diligence activities and audits when necessary
Decision Making and Problem Solving, including an understanding of decision-making models and methodology
Influence, Cross-Functional Collaboration and Organizational Awareness, including demonstrating professional maturity, including understanding own strengths and receptivity to feedback
Agility and Proactivity, including an ability to anticipate risks or issues to program or business and take the necessary steps to mitigate or address
Leadership, such as skill in clearly communicating objectives, goals, and expectations to others
Communication, including an ability to provide context and articulate key messages effectively and with appropriate level of detail
Strategic Thinking and Planning, such an ability to set short-term and longer-term goals for individual objectives and task completion
Health Agency Submission Regulations and Process, such as demonstrated ability to provide an assessment of impact of new or modified regulations and guidance on submission processes and the ability to anticipate technical filing issues based on guidance and emerging issues throughout the submission process and proposes solutions.
Formatting and Publishing, able to prepare complex filings in accordance with departmental procedures independently and diagnose and resolve a majority of complex technical questions across different submission types
Drug Development and Product Knowledge, such as demonstrated knowledge of basic milestone documentation that happens along the clinical development pathway and why it is important. Also being familiar with the key considerations associated with product development, particularly as they apply to the regulatory function (e.g. labels, indications, safety)
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Regulatory Affairs has been defined and is available to employees of BioMarin.
May manage a direct report
EDUCATION AND EXPERIENCE
· Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
· 2 + year experience with PhD; 4+ years with Masters, 6+ with bachelor’s degrees
· Regulatory Operations / Regulatory Submission experience preferred
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.